The 2016 Michigan Research Ethics Conference was held April 29, 2016 at Michigan State University’s Kellogg Center. There were over 200 attendees, including IRB chairs and members, human subjects protections staff and administrators, research ethics scholars, and others. The conference’s theme was “A DEEPER DIVE into Human Subject Protections.”

Center Director Dr. Tom Tomlinson conducted a breakout session on “Ethical Challenges for Research in the Acute Care Setting.”

Abstract: Research conducted with patients who are acutely ill from stroke, heart attack, sepsis, or other life-threatening conditions raise a number of special ethical questions. When the subject cannot provide an informed consent, is assent sufficient? When the nature of the research requires that it begin in an emergent situation, can subjects be enrolled prior to any consent? What is the boundary between research and treatment in these circumstances and how can subjects or their surrogates be helped to understand it? Can the stringency of informed consent be relaxed when these studies pose “minimal risk”? What could “minimal risk” mean in these circumstances?

Using case examples, Dr. Tomlinson explored these and other challenges together with the breakout session attendees.